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Acute Lymphocytic LeukemiaPhase 1/2NCT02851589

Study Evaluating the Efficacy and Safety of PCAR-019 in CD19 Positive Relapsed or Refractory Leukemia and Lymphoma

A Phase 1/2 study testing PCAR-019 (anti-CD19 CAR-T cells) in people with Acute Lymphocytic Leukemia and Chronic Lymphocytic Leukemia, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell immunotherapy in patients with CD19 positive relapsed or refractory Leukemia and Lymphoma. Read more about this study

Who is it for?
Ages 14 years and older
What is being tested?
PCAR-019 (anti-CD19 CAR-T cells)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
Jul 2016to Nov 2019
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male and female subjects with CD19+ B cell malignancies in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled:
  • Eligible diseases: Acute lymphocytic leukemia (ALL), Chronic lymphocytic leukemia (CLL), Follicular lymphoma, Mantle cell lymphoma, B-cell prolymphocytic leukemia, and diffuse large cell lymphoma, previously identified as CD19+.
  • Patients 14 years of age or older, and must have a life expectancy > 12 weeks.
  • Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60.
  • Adequate venous access for apheresis or venous sampling, and no other contraindications for leukapheresis.
  • Females of child-bearing potential must have a negative pregnancy test and all subjects must agree to use an effective method of contraception for up to two weeks after the last infusion of CAR T cells.
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: White blood cell count (WBC) ≥ 2500c/ml, Platelets ≥ 50×10^9/L, Hb ≥ 6.0g/dL, lymphocyte (LY) ≥ 0.7×10^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase < 1.5×upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration.
  • Ability to give informed consent.

Who cannot join

  • The transduction efficiency of the T cells is less than 30% or the amplification of the T cells via artificial antigen presenting cell (aAPC) stimulation is less than 5 times.
  • Pregnant or nursing women may not participate.
  • Active HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders.
  • History of severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or aldesleukin.
  • Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
Show all 10Show fewer
  • The existence of unstable or active ulcers or gastrointestinal bleeding.
  • Patients need anticoagulant therapy (such as warfarin or heparin).
  • Patients need long-term antiplatelet therapy (aspirin at a dose > 300mg/d; clopidogrel at a dose > 75mg/d).
  • Patients using fludarabine or cladribine chemotherapy within 3 months prior to leukapheresis.

Trial locations and contacts

1 site in 1 country.

Lin Yang, Ph.D. contact

86-512-65922190

info@persongen.com

China1 site, 1 recruiting

  • PersonGen BioTherapeutics (Suzhou) Co., Ltd.

    Suzhou, Jiangsu, 215123

    Lin Yang, Ph.D., 86-512-65922190, info@persongen.com

    Recruiting

Other trials in China

About this study

The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell immunotherapy in patients with CD19 positive relapsed or refractory Leukemia and Lymphoma.

Being tested
PCAR-019 (anti-CD19 CAR-T cells)
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Leukemia, Prolymphocytic, B-Cell, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCAR-019 (anti-CD19 CAR-T cells)Biological

    Also called chimeric antigen receptor T cells with specificity for CD19

Study groups in NCT02851589
Study groupRoleWhat they receive
PCAR-019ExperimentalEnrolled patients will receive PCAR-019 with a novel specific chimeric antigen receptor targeting CD19 antigen by infusion.
Receives: Biological: PCAR-019 (anti-CD19 CAR-T cells)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I: Adverse events attributed to the administration of PCAR-019

    Measured: 2 years

Secondary outcomes (1)

  1. Phase II: Objective Response Rate

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionNov 2018 (estimated)
  4. Study completionNov 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02851589
Sponsor's protocol ID
PG-019-002
Status last verified
Jul 2016
First submitted
28 Jul 2016
Last updated
1 Aug 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PCAR-019 (anti-CD19 CAR-T cells) in people with Acute Lymphocytic Leukemia and Chronic Lymphocytic Leukemia, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lin Yang, Ph.D. (86-512-65922190, info@persongen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: Adverse events attributed to the administration of PCAR-019 (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02851589.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2016.

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